Twelve infant deaths over the last 13 years have been blamed on the positioners, and the agencies have received many more reports of parents finding their babies in hazardous situations when they rolled on their side or stomach. Although many parents believe the positioners will protect their child from SIDS, and some manufacturers make such claims, there haven’t been any studies that link them with safer sleep, said Dr. Joshua Sharfstein, FDA Principal Deputy Commissioner and a pediatrician.

Sleep positions come in both wedge and side bolster form, but parents are advised against using either. Babies should always be put to sleep on their back, with no pillows, blankets or stuff animals in the crib.